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Echosens

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K223902	FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)	IYO	2023-03-02	View
510(k)	K212035	FibroScan 230	IYO	2021-07-30	View
510(k)	K203273	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)	IYO	2021-03-25	View
510(k)	K200655	FibroScan® 630	IYO	2020-07-16	View
510(k)	K181547	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)	IYO	2018-07-09	View
510(k)	K173034	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)	IYO	2017-11-14	View
510(k)	K172142	FibroScan 430 Mini+	IYO	2017-09-13	View
510(k)	K160524	FibroScan 530 Compact	IYO	2016-03-18	View
510(k)	K123806	FIBROSCAN	IYO	2013-04-05	View

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